Kornimate/medical-research-clean huggingface dataset:
fat layer reduction in the lateral thighs using coolsculpting

Conditions: Body Fat Disorder

Summary: evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.

evaluation of the zeltiq coolsculpting system for non-invasive subcutaneous fat reduction in the lateral thighs.

Eligibility criteria:
inclusion criteria: * male or female subjects \> 22 years of age and \< 65 years of age. * subject has clearly visible fat on the intended treatment area (lateral thighs), which in the investigator's opinion, may benefit from the treatment. * subject has not had weight change exceeding 10 pounds in the preceding month. * subject with body mass index (bmi) up to 35. bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. * subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study. * subject has read and signed a written informed consent form. exclusion criteria: * subject has had a surgical procedure(s) in the area of intended treatment. * subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. * subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 4 months. * subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. * subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * subject is taking or has taken diet pills or supplements within the past month. * subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). * subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system * subject is pregnant or intending to become pregnant during the study period (in the next 4 months). * subject is lactating or has been lactating in the past 6 months. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
multiple daily condensed tannin supplementation and iron bioavailability: the tannin dose response trial

Conditions: Iron Deficiency Anemia; Iron-deficiency

Summary: tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral complexes, and have thus been termed 'antinutritional.' despite this, there is evidence that adaptation to similar antinutritional factors is possible when consumed over time. limitations in current studies include short (single meal) duration, and use of incongruent tannin types from the condensed tannins that are commonly consumed. if adaptation to tannins does happen, it may be due to salivary proline-rich proteins, which have been found to be protective of iron status in animal models. the primary objectives of this study are: 1) to determine whether condensed tannins impact iron bioavailability or status when consumed in multi-dose, multiple daily supplements and 2) to test whether salivary protein production may impact iron bioavailability with tannin supplementation. secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption. the study has been conducted in an iron absorption study of 11 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95% proanthocyanidin rich grape seed extract before and after regular, three times daily supplementation for four weeks. each participant consumed all three concentrations of supplement over the 26-week study, with a two-week washout between interventions. direct iron absorption was measured using area under the curve. iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on hplc. astringency testing was conducted at the end of each meal challenge. iron absorption and status markers were analyzed by anova, and mixed-modeling followed by pairwise comparison by least significant differences. pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability. the present study will provide important information regarding the approximate influence of condensed tannin consumption on iron bioavailability and storage over time, at different doses. data will also help to delineate possible physiological mechanisms underlying tannin adaptation and possible ways to detect individuals who better adapt than others.


Eligibility criteria:
inclusion criteria: * female, 18-35 years old * non-obese bmi (18-29.9) * signed informed consent exclusion criteria: * oral disease * gastrointestinal disease * tobacco user * heavy alcohol user * pregnancy (assessed by pregnancy test) * lactation * medications affecting iron bioavailability * vitamin or mineral supplementation (other than vitamin b12)

Keywords: antinutrients tannins proanthocyanidins salivary proline-rich proteins
post exposure treatment with doxycycline for the prevention of relapsing fever

Conditions: Relapsing Fever, Tick-borne; Jarisch Herxheimer Reaction

Summary: abstract background tick-borne relapsing fever (tbrf) is an acute febrile illness. in israel, tbrf is caused by borrelia persica and is transmitted by ornithodoros tholozani ticks. we examined the safety and efficacy of a post exposure treatment policy to prevent tbrf. methods in a double blind, placebo controlled trial 93 healthy volunteers with suspected tick exposure (51 with bite signs and 42 contacts) were randomly assigned to receive either doxycycline (200 mg for the first day and 100mg/d for 4 days) or placebo, approximately 2 days after contact. blood smears were examined for borrelia at inclusion and during fever rise. serology for lyme disease cross- reactivity and pcr for borrelia glpq gene were also performed. cases of tbrf were defined as subjects having fever and a positive blood smear.


Eligibility criteria:
inclusion criteria: * suspected exposure to tick-borne relapsing fever * after returning from field exercise in a tick-borne relapsing fever infected area * having a tick bite or staying in field in close proximity to a subject with tick bite sign exclusion criteria: * known sensitivity to tetracycline or doxycycline * febrile illness on recruitment
a maintenance extension of phase i pilot study of chimeric anti-cd4 antibody m-t412 in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: objectives: i. evaluate the safety and immunogenicity of single and multiple doses of m-t412, a chimeric murine-human anti-cd4 monoclonal antibody, in patients with multiple sclerosis. ii. evaluate the pharmacokinetics of m-t412. iii. obtain preliminary data on the clinical response to m-t412.

protocol outline: this is an open label, dose escalating study. escalating doses of m-t412 are administered to cohorts of 5 patients each receiving a single dose intravenously over 2 hours. patients who complete the single dose assessment of m-t412 may receive up to 3 additional single doses of m-t412 iv over 2 hours, with each repeated dose given at least 1 month apart. then, patients receive one dose level of m-t412 iv over 2 hours at 3 month intervals over a period of 12 months for a total of 5 doses. once recovery of cd4 cells is obtained, the next scheduled infusion of m-t412 begins. patients are omitted from study if cd4 cells remain attenuated following 2 scheduled infusion sessions. patients are followed at 3, 6, 12, and 24 months after the first infusion.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of chronic, advanced, progressive multiple sclerosis (ms) --prior/concurrent therapy-- * biologic therapy: no sensitivity to murine proteins no prior treatment at any time with anti-cd4 antibodies, other murine antibodies, or other anti-t cell antibodies (e.g., xenologous or human) at least 4 weeks since use of other biological agents * chemotherapy: no concomitant chemotherapy at least 3 months since prior chemotherapy * endocrine therapy: no concomitant steroidal therapy at least 3 months since prior steroidal therapy * radiotherapy: no total lymphoid irradiation prior to study no concomitant radiotherapy at least 3 months since prior radiotherapy * other: no use of investigational drugs within 30 days prior to study --patient characteristics-- * age: 21 to 75 * hematopoietic: hemoglobin at least 10 g/dl wbc at least 4000/mm3 granulocyte count at least 1500/mm3 platelet count at least 100,000/mm3 cd4+ lymphocyte count at least 300 cells/mm3 * other: not pregnant or lactating effective contraception required of fertile patients for 3 months prior to and during study no substance abuse (e.g., drug or alcohol) not hiv positive no aids-related complex (arc) no serum antibodies to hiv negative serum antibody test for hiv within 1 month prior to study no underlying medical or psychiatric condition

Keywords: multiple sclerosis neurologic and psychiatric disorders rare disease
lactic acid levels in hypotensive patients without(standard) and with tourniquet

Conditions: Hypotension; Sepsis

Summary: this study seeks to determine whether the lactic acid blood level in a critically ill patient must be drawn with a non-tourniquet venipuncture. the null hypothesis is that there is no significant difference in lactic acid blood level in critically ill patients in a sample taken from either with a tourniquet or a non-tourniquet veni-puncture. monitoring of lactic acid level is helpful in both identifying potentially serious ill patients as well as identifying in the icu patients with high morbidity and mortality. when a patient arrives to an emergency department and that patient is hypotensive (bp less than or equal to 90 systolic), the nursing staff often starts an iv and if possible draws the patient's initial blood tests off that first iv site; or if the patient has had an iv started in the field by ems, the nursing staff will draw blood from another site using a tourniquet. this initial work up by the nursing staff takes 15 -20 minutes before a physician may see the patient. since the present standard lactic acid test must be drawn either by arterial puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the rns) initial blood draws. this simple impediment of needing to repeat the venipuncture without a tourniquet, especially in patients who often have venous access difficulty, delays the identification of appropriate patients for early and aggressive management- particularly those with sepsis. our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.


Eligibility criteria:
inclusion criteria: * blood pressure systolic of 90 or less * non pregnant by history exclusion criteria: * pregnant by history * comfort care only

Keywords: lactic acid hypotension sepsis
a study of abt-888 in combination with carboplatin and gemcitabine in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to determine the maximum tolerated dose of veliparib (abt-888)and to establish the recommended phase 2 dose of veliparib (abt-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option. * eastern cooperative group performance score of 0 to 2. * adequate hematologic, hepatic and renal function * subject has received up to 2 dna damaging or cytotoxic regimens in the past five years exclusion criteria: * subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration. * subjects with known history of brain metastases and primary cns tumors. * hypersensitivity reactions to platinum compounds or gemcitabine. * clinically significant and uncontrolled major medical conditions * active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.

Keywords: parp inhibitors
it-supported early treatment of childhood overweight

Conditions: Childhood Obesity; Technology Based Obesity Intervention

Summary: the goal of this exploratory/ developmental study is to develop and evaluate an integrated information system, healthy eating and activity today (heat), for promoting self-care in overweight children. heat is comprised of two components: 1)telephone linked care-heat (tlc-heat), a self-care intervention delivered at home through totally automated telephone conversations; and 2) primary care-heat (pc-heat), a primary care intervention linked with tlc-heat and delivered through an electronic health record (ehr). the heat system will guide children in the early stages of overweight, i.e., children with body mass index (bmi) 0-3 bmi points above the 95th percentile for age and gender, toward healthy weight management and assist the child's parent(s) and primary care provider (pcp) to support the child's efforts.

for this project we will: 1) develop tlc-heat for use by children in the earliest stage of overweight and their parents; 2) integrate tlc-heat with an electronic health record to provide child- and parent-reported behavior summaries combined with evidence-based decision support to primary care providers (pcps) at the point-of-care (pc-heat); and 3) conduct a pilot study of the combined heat system to explore the appropriateness of conducting a larger, randomized clinical trial in the future.

Eligibility criteria:
inclusion criteria: * children will be enrolled in the study if they meet a set of eligibility criteria which includes: 1. 0-3 bmi points above the 95th %ile for age and gender 2. age 9-12 years old 3. a pcp at bmc 4. an english speaking child and parent (based on interviewer assessment). exclusion criteria: * children will be considered ineligible for the study if they: 1. have a health condition for which dietary recommendations in tlc-heat would be contraindicated 2. have cognitive impairment (not in a mainstream academic class in school) 3. have a terminal illness, current or former diagnosis of an eating disorder, or other diagnosis that the pcp deems should exclude them from participation 4. plan to move away from the boston area in less than 12 months 5. are participating in another clinical weight treatment program. * initial screening will be done by research assistants over the phone.

Keywords: childhood obesity obesity intervention
recombinant adeno-associated virus administration for patients with menkes syndrome

Conditions: Menkes Syndrome

Summary: it is a single-center, open, single-arm, non-randomized investigator-initiated trial evaluating the efficacy and safety of recombinant adeno-associated virus administration for patients with menkes syndrome.

who can participate? patients with menkes syndrome were diagnosed by combining clinical and genetic diagnoses. how to conduct this study? in this study, the constructed recombinant adeno-associated virus preparation will be delivered to patients with menkes syndrome. after administration, close follow-up will be conducted for at least three months, followed by regular follow-up until at least the 12th month. the efficacy and safety of treatment will be observed and evaluated. after the completion of the study, participants will decide whether to participate in the long-term follow-up program for five years. what are the possible benefits and risks of participating? benefits: this study may prolong the life span and improve the prognosis of menkes syndrome subjects. the information obtained from this study will help determine what treatment may be safe and effective for other subjects with similar conditions. risks: subjects may have adverse reactions to the treatment. these adverse reactions may include abnormal liver injury, fever, thrombocytopenia, thrombotic microangiopathy, and possibly others. where is the study run? kunming hope of health hospital.

Eligibility criteria:
inclusion criteria: 1. the definitive diagnosis of menkes disease is determined by molecular genetic confirmation of atp7a mutations. 2. disorder of copper metabolism with the serum copper \< 50 ug/dl (reference 70-180 ug/dl) and ceruloplasmin \< 20 mg/dl (reference 20-45 mg/dl) in the absence of copper supplement injection. 3. clinical onsets of developmental retardation, seizures, and hypotonia with delay in poor head control and inability to sit at the age of 2-3 months. 4. willingness to complete the informed consent process and to comply with study procedures and visit schedule. 5. willingness to agree with the demand of nasal or gastrostomy feeding for nutrition maintenance in the opinion of the investigator. exclusion criteria: 1. inability to be accepted for delivering the investigational medical product due to failure to recover from severe or acute diseases. 2. presence of specific anti-aav antibodies. 3. active viral infection (includes hiv, covid-19, or serology positive for hepatitis b or c). 4. allergy to the substance or excipients in the investigational medical product solution. 5. previous or current participation in any other gene therapies. 6. severe abnormality of hepatic, renal, and cardiac function.

Keywords: gene therpy adeno-associated virus
the effect of vitamin c on post-orthodontic treatment relapse

Conditions: Orthodontic Relapse

Summary: the aim of this study is to evaluate and compare the effect of locally injected and orally administered (systemic) vitamin c on post-orthodontic treatment relapse


Eligibility criteria:
inclusion criteria: * patients who were indicated for non-extraction orthodontic treatment. * adult patients with finished orthodontic treatment, using fixed appliance therapy. * patients with good oral hygiene, and a healthy periodontal condition. exclusion criteria: * patients who received sectional fixed appliance therapy. * patients with hypodontia requiring tooth replacement in the retainer, as a temporary measure. * patients requiring fixed bonded retainers. * pregnant and lactating women. * patients with hereditary hemochromatosis. * cancer patients, receiving chemotherapy. * patients with chronic diseases such as diabetes, or those receiving drugs such as corticosteroids, both of which that may affect tooth movement.
epidemiology of chronic pain as part of the post-intensive care syndrome

Conditions: Critical Care; Chronic Pain

Summary: post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after icu discharge and responsible of disabilities and decrease of quality of life. nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. the aim of the study is to determine the incidence and the risks factors of chronic pain after icu.

post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. these chronic health issues bear tremendous burden for patients and next-of-kin. among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. in the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. the investigators have addressed these patients to pain care specialists, with successful treatment success. however, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. the incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge. the aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. the investigators intend to describe the incidence of chronic pain assessed with a simple verbal score ≥ 3, 3 months after the icu admission. the investigators also intend to describe the incidence of painful symptoms, at icu discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the id-pain scale. the evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. the investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis. the investigators are performing a nation-wide multicentric study. at this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.

Eligibility criteria:
inclusion criteria : * all patients admitted in icu * icu length-of-stay ≥ 48 hours * no major cognitive impairment that could prevent pain evaluation exclusion criteria : * patient under 18-year-old * patient under guardianship * patient unable to communicate or quantify pain with a verbal score and id-pain score * refusal to participate

Keywords: pics post intensive care syndrome chronic pain critical care